MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 3 LAT; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.243

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

On 17 july 2017 the medical affairs director performed a clinical evaluation and commented as follows: femoral stem loosening in cementless tha less than 1 year after primary.No contact or osseointegration is visible from the pre-revision x-rays.According to report, the patient's bone quality was deemed poor, a known and reported partial contraindication to a cementless implant.Signs are radiographically visible that may be consequent to a fracture fixation implant, this may have contributed to poor bone quality, in spite of young age of the patient.We see no reason to ascribe this failure to a faulty device.Batch review performed on 19july 2017.(b)(4).

Event Description

The patient came in complaining of pain.The surgeon determined the stem was loose.The loosening was due to poor bone quality.The surgeon revised the stem, head and liner.The surgery was completed successfully.Explants are not available.

• Brand Name: AMISTEM COLLARED HA COATED STEM SIZE 3 LAT
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6727727
• MDR Text Key: 80521594
• Report Number: 3005180920-2017-00392
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804687
• UDI-Public: 07630030804687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2020
• Device Catalogue Number: 01.18.243
• Device Lot Number: 155255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR